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Bupivacaine Effectiveness and Safety in SABER® Trial

NCT01052012 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2021-06-01

Study results available
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Summary

This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain.

The purpose of this study is to investigate safety (side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following various kinds of abdominal surgeries.

Conditions

  • Postoperative Pain
  • Abdominal Surgery

Interventions

DRUG

SABER-Bupivacaine

Injectable Extended Release Solution; SABER-Bupivacaine /Once

DRUG

Bupivacaine HCl

Injectable Solution; Bupivacaine HCl /Once

DRUG

SABER-Placebo

Injectable Solution; SABER-Placebo/Once

Sponsors & Collaborators

  • Nycomed

    collaborator INDUSTRY

  • Hospira, now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Durect

    lead INDUSTRY

Principal Investigators

  • Dmitri Lissin, MD · Durect

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01052012 on ClinicalTrials.gov